Question:Is there randomized controlled trial evidence to support the use of information provision in people with stroke and their caregivers?

Clinical Answer:

There is insufficient published randomized controlled trial evidence on the efficacy of information provision to stroke survivors and their care-givers to draw conclusions on the utility of these interventions for improving patient knowledge about stroke and the  stroke services available to them or for improving their quality of life.

Across four trials (327 participants) passive provision of information was associated with a small increase in stroke survivors’ knowledge about stroke and stroke services.  Studies used differing methods to provide information and so it is difficult to know how to translate these results into practice.  Only one small study (33 participants) looked at care-givers’ knowledge after passive information provision; with such a small sample size, firm conclusions cannot be drawn.  The effect of “active” information provision, where participants engaged with the education materials, has also been described, and was associated with increased knowledge in both stroke survivors (two studies, 209 participants) and their care-givers (three studies, 303 participants).  For both active and passive information provision there was no obvious beneficial effect on measures of depression and anxiety, activities of daily living, societal participation, quality of life, or use of services, but the trials were generally underpowered and not combined in meta-analyses.

These summary data come with certain caveats: there was substantial variability across the studies; study sizes were small and so even the pooled analysis may have had insufficient participants to see a true treatment effect; and certain aspects of study design may have introduced bias (lack of blinding; losses to follow up) which may compromise the validity of the results.

Full outcome data is detailed below:

1.Passive information provision versus usual care

  • Population, Intervention, Comparator

    Population:

    Adults who had suffered a stroke (most were elderly, with a slightly higher proportion of men than women) and their caregivers. For most studies the time since stroke, the severity of stroke, or whether patients had had prior stroke(s), was not reported

    Intervention:

    Passive information: Written generic information about stroke in the form of booklets and leaflets (3 trials), or individualized information in the form of (1 trial each): booklets; a copy of their medical history, clinical résumés, test results and leaflets; multimedia computer program; information presented by a research registrar; information pack containing information about physical, cognitive and emotional effects of stroke, carer well-being and local services; or a patient-held record that included telephone numbers, generic stroke information and fact sheets

    Comparator:

    Usual care. The constituents of usual cared differed across trials, including: health summary sheet listing medication; discussion of test results and standard health education; stroke information leaflets; baseline interview with a research nurse and the Stroke Association of Queensland fact sheet; or advice from therapists and leaflets from the Chest, Heart and Stroke Association

  • OUTCOME 1.1: Patient knowledge about stroke/stroke services

    Risk of bias of studies:

    The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants or caregivers, three (75%) did not report blinding outcome assessors, one (25%) failed to report adequate allocation concealment and one (25%) random sequence generation; all four had high or unclear numbers of withdrawals.

    Narrative result:

    Four RCTs with 327 participants found that the knowledge of patients receiving passive information was greater compared with those receiving the controls. All studies used different questionnaires so the reviewers calculated a standardized mean difference. These are hard to interpret clinically but rules of thumb in their interpretation suggest that 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen J. Statistical Power Analysis in the Behavioral Sciences (2nd edition). Hillsdale (NJ): Lawrence Erlbaum Associates, Inc., 1988).

    Relative effect or mean difference:

    There was a statistically significant difference between groups, in favor of passive information (standardized mean difference 0.26, 95% CI 0.04 to 0.48).

    Forest plot from Cochrane Review

    Reference:
    Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
    • OUTCOME 1.2: Carer knowledge about stroke/stroke services

      Risk of bias of studies:

      The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial failed to report blinding participants, caregivers or outcome assessors; adequate allocation concealment or random sequence generation methods were used and numbers of withdrawals were low.

      Narrative result:

      One RCT with 33 participants found no statistically significant difference between groups; the trial would have been underpowered to detect any clinically significant difference.

      Relative effect or mean difference:

      There was no statistically significant difference between groups (standardized mean difference 0.28, 95% CI -0.42 to 0.97).

      Forest plot from Cochrane Review

      Reference:
      Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
      • OUTCOME 1.3: Number of patients experiencing anxiety

        Risk of bias of studies:

        The reviewers did not perform a GRADE assessment of the quality of the evidence. None the three trials reported blinding participants or caregivers, one (33%) did not report blinding outcome assessors, one (33%) failed to report adequate allocation concealment or random sequence generation; one had high numbers of withdrawals.

        Narrative result:

        Three RCTs with 227 participants found no statistically significant difference between groups; the analysis is likely to be underpowered to detect clinically meaningful differences.

        Relative effect or mean difference:

        There was no statistically significant difference between groups (Peto OR 1.64, 95% CI 0.80 to 3.37).

        Forest plot from Cochrane Review

        Absolute effect:

        There was no statistically significant difference between groups.

        Reference:
        Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
        • OUTCOME 1.4: Number of patients experiencing depression

          Risk of bias of studies:

          The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants or caregivers, two (50%) did not report blinding outcome assessors, two (50%) failed to report adequate allocation concealment and/or random sequence generation; two (50%) had high numbers of withdrawals.

          Narrative result:

          Four RCTs with 311 participants found no statistically significant difference between groups; the analysis is likely to be underpowered to detect clinically meaningful differences.

          Relative effect or mean difference:

          There was no statistically significant difference between groups (Peto OR 1.57, 95% CI 0.85 to 2.93).

          Forest plot from Cochrane Review

          Absolute effect:

          There was no statistically significant difference between groups.

          Reference:
          Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
          • OUTCOME 1.5: Activities of daily living

            Risk of bias of studies:

            The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants or caregivers, three (75%) did not report blinding outcome assessors, two (50%) failed to report adequate allocation concealment or random sequence generation, three (75%) had high or unclear numbers of withdrawals.

            Narrative result:

            None of the four trials, with a total of 280 participants, found a statistically significant difference between groups; the trials are likely to be underpowered to detect clinically meaningful differences.

            Relative effect or mean difference:

            The studies were not meta-analyzed; results are presented in a narrative only.

            Reference:
            Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
            • OUTCOME 1.6: Participation

              Risk of bias of studies:

              The reviewers did not perform a GRADE assessment of the quality of the evidence. None the three trials reported blinding participants, caregivers or outcome assessors, one (50%) failed to report adequate allocation concealment and one (25%) random sequence generation; all three had high or unclear numbers of withdrawals.

              Narrative result:

              None of the three trials, with a total of 258 participants, found a statistically significant difference between groups; the trials are likely to be underpowered to detect clinically meaningful differences.

              Relative effect or mean difference:

              The studies were not meta-analyzed; results are presented in a narrative only.

              Reference:
              Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
              • OUTCOME 1.7: Social activities

                Risk of bias of studies:

                The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial did not reported blinding participants or caregivers, failed to report adequate allocation concealment or random sequence generation and had unclear numbers of withdrawals; outcome assessors were blinded.

                Narrative result:

                One trial with 36 participants found no statistically significant difference between groups; the trial would have been underpowered to detect any clinically significant difference.

                Reference:
                Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                • OUTCOME 1.8: Perceived health status/quality of life

                  Risk of bias of studies:

                  The reviewers did not perform a GRADE assessment of the quality of the evidence. Neither trial reported blinding participants or caregivers and one (50%) did not report blinding outcome assessors. Both trials had adequate allocation concealment and random sequence generation, and low numbers of withdrawals.

                  Narrative result:

                  Neither of the two trials, with a total of 231 participants, found a statistically significant difference between groups when using the Dartmouth COOP Charts; the trials would have been underpowered to detect any clinically significant difference.

                  Relative effect or mean difference:

                  The studies were not meta-analyzed; results are presented in a narrative only.

                  Reference:
                  Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                  • OUTCOME 1.9: Service use

                    Risk of bias of studies:

                    The reviewers did not perform a GRADE assessment of the quality of the evidence. The trial failed to report blinding participants, caregivers or outcome assessors; adequate allocation concealment or random sequence generation methods were used and numbers of withdrawals were low.

                    Narrative result:

                    One trial with 93 participants found no statistically significant difference between groups; the trial would have been underpowered to detect any clinically significant difference.

                    Relative effect or mean difference:

                    The studies were not meta-analyzed; results are presented in a narrative only.

                    Reference:
                    Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]

                    2.Active information provision versus usual care

                    • Population, Intervention, Comparator

                      Population:

                      Adults who had suffered a stroke (most were elderly, with a slightly higher proportion of men than women) and their caregivers. For most studies the time since stroke, the severity of stroke, or whether patients had had prior stroke(s), was not reported

                      Intervention:

                      Active information: Program of lectures (4 trials), workbook providing information about stroke, task material such as goal setting and an audio relaxation tape (1 trial), information delivered by a pharmacist over six sessions (1 trial), lectures for caregivers with weekly follow-up at home by health service volunteers (1 trial), or a multicomponent intervention (5 trials) that consisted of (1 trial each): instruction on a range of topics plus hands-on training; a recovery plan, an interactive workbook and a weekly phone call from a researcher; communication strategies, relaxation and stress management; information manual and fortnightly meetings with a multidisciplinary team; or a monthly review by a stroke nurse specialist, relevant written information, and personalized records detailing individual risk factors and targets

                      Comparator:

                      Usual care: The constituents of usual care differed across studies. Some trials gave no definition, whilst others reported using information on stroke and its consequences (during hospitalization and/or at/after discharge), prevention and management options, goal setting, rehabilitation and discharge planning, encouragement to attend nursing and therapy activities, generic risk factor advice

                    • OUTCOME 2.1: Patient knowledge about stroke/stroke services

                      Risk of bias of studies:

                      The reviewers did not perform a GRADE assessment of the quality of the evidence. Neither trial reported blinding participants or caregivers, one trial (50%) failed to report adequate random sequence generation, and one trial had high numbers of withdrawals. Both trials adequately concealed allocation and blinded outcome assessors.

                      Narrative result:

                      Two RCTs with 209 participants found that treatment increased patient knowledge compared with control. As the studies used different scales to assess this outcome, the reviewers calculated a standardized mean difference. These are hard to interpret clinically but rules of thumb in their interpretation suggest that 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen J. Statistical Power Analysis in the Behavioral Sciences (2nd edition). Hillsdale (NJ): Lawrence Erlbaum Associates, Inc., 1988).

                      Relative effect or mean difference:

                      There was a statistically significant difference between groups, in favor of active information (standardized mean difference 0.34, 95% CI 0.07 to 0.61).

                      Forest plot from Cochrane Review

                      Reference:
                      Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                      • OUTCOME 2.2: Carer knowledge about stroke/stroke services

                        Risk of bias of studies:

                        The reviewers did not perform a GRADE assessment of the quality of the evidence. None the three trials reported blinding participants, caregivers and one (25%) failed to report blinding of outcome assessors. One (25%) failed to report adequate random sequence generation and one (25%) allocation concealment; one (25%) had high numbers of withdrawals.

                        Narrative result:

                        Three RCTs with 303 participants found that treatment increased carer knowledge compared with control. The studies used different questionnaires so the reviewers calculated a standardized mean difference. These are hard to interpret clinically but rules of thumb in their interpretation suggest that 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen J. Statistical Power Analysis in the Behavioral Sciences (2nd edition). Hillsdale (NJ): Lawrence Erlbaum Associates, Inc., 1988).

                        Relative effect or mean difference:

                        There was a statistically significant difference between groups, in favor of active information (standardized mean difference 0.88, 95% CI 0.05 to 1.70).

                        Forest plot from Cochrane Review

                        Reference:
                        Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                        • OUTCOME 2.3: Number of patients experiencing anxiety

                          Risk of bias of studies:

                          The reviewers did not perform a GRADE assessment of the quality of the evidence. None the three trials reported blinding participant or caregivers, one (50%) failed to report adequate random sequence generation, and one had high numbers of withdrawals; all three trials blinded outcome assessors and had adequate allocation concealment.

                          Narrative result:

                          Three RCTs with 454 participants found no statistically significant difference between groups.

                          Relative effect or mean difference:

                          There was no statistically significant difference between groups (Peto OR 0.61, 95% CI 0.35 to 1.07).

                          Forest plot from Cochrane Review

                          Absolute effect:

                          There was no statistically significant difference between groups.

                          Reference:
                          Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                          • OUTCOME 2.4: Number of patients experiencing depression

                            Risk of bias of studies:

                            The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants or caregivers, two (50%) failed to report adequate random sequence generation, and one had high numbers of withdrawals; all four blinded outcome assessors and adequately concealed allocation.

                            Narrative result:

                            Four RCTs with 645 participants found no statistically significant difference between groups.

                            Relative effect or mean difference:

                            There was no statistically significant difference between groups (Peto OR 0.63, 95% CI 0.38 to 1.03).

                            Forest plot from Cochrane Review

                            Absolute effect:

                            There was no statistically significant difference between groups.

                            Reference:
                            Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                            • OUTCOME 2.5: Activities of daily living

                              Risk of bias of studies:

                              The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants, caregivers and one (25%) failed to blind outcome assessors. Two (50%) failed to report adequate random sequence generation, and one (25%) had high numbers of withdrawals; all four adequately concealed allocation.

                              Narrative result:

                              None of the four trials, with a total of 712 participants, found a statistically significant difference between groups.

                              Relative effect or mean difference:

                              The studies were not meta-analyzed; results are presented in a narrative only.

                              Reference:
                              Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                              • OUTCOME 2.6: Participation

                                Risk of bias of studies:

                                The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants, caregivers and one (25%) failed to blind outcome assessors. Three (75%) failed to report adequate random sequence generation and one (25%) random sequence generation; one (25%) had unclear numbers of withdrawals.

                                Narrative result:

                                None of the four trials, with a total of 713 participants, found a statistically significant difference between groups.

                                Relative effect or mean difference:

                                The studies were not meta-analyzed; results are presented in a narrative only.

                                Reference:
                                Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                                • OUTCOME 2.7: Social activities

                                  Risk of bias of studies:

                                  The reviewers did not perform a GRADE assessment of the quality of the evidence. Neither trial reported blinding participants or caregivers; one failed to report adequate allocation concealment, and one random sequence generation; one had high numbers of withdrawals.

                                  Narrative result:

                                  Neither of the two trials, with a total of 374 participants, found a statistically significant difference between groups; one used the Nottingham extended activities of daily living scale, and the other the Frenchay activities index. The trials are likely to be underpowered to detect clinically meaningful differences.

                                  Relative effect or mean difference:

                                  The studies were not meta-analyzed; results are presented in a narrative only.

                                  Reference:
                                  Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                                  • OUTCOME 2.8: Perceived health status/quality of life

                                    Risk of bias of studies:

                                    The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants, caregivers and one (25%) failed to blind outcome assessors. Two (50%) failed to report adequate random sequence generation, and one (25%) had high numbers of withdrawals; all four adequately concealed allocation.

                                    Narrative result:

                                    Of the four trials (a total of 750 participants), three reported no statistically significant difference between groups using the MOS 36-item short-form health survey, the Functional Limitations Profile, or the EuroQol. One trial reported significantly improved quality in life as measured by the EuroQol visual analogue scale at three and 12 months in patients whose caregivers had received training (intervention) compared with those who had received conventional care (P = 0.019 and P = 0.009, respectively).

                                    Reference:
                                    Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]
                                    • OUTCOME 2.9: Service use

                                      Risk of bias of studies:

                                      The reviewers did not perform a GRADE assessment of the quality of the evidence. None the four trials reported blinding participants, caregivers and one (25%) failed to report blinding of outcome assessors. One (25%) failed to report adequate random sequence generation and one (25%) allocation concealment; one (25%) had high numbers of withdrawals.

                                      Narrative result:

                                      None of the four trials, with a total of 814 participants, found a statistically significant difference between groups.

                                      Relative effect or mean difference:

                                      The studies were not meta-analyzed; results are presented in a narrative only.

                                      Reference:
                                      Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]

                                      Additional Information:

                                      DOI

                                      10.1002/cca.407

                                      Publication Dates

                                      1. Published Online: 30 JUL 2014

                                      CCA derived from

                                      Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, Young J. Information provision for stroke patients and their caregivers. Cochrane Database of Systematic Reviews 2012, Issue 11. Art. No.: CD001919. DOI: 10.1002/14651858.CD001919.pub3. [Review search date: June 2012]

                                      How to Cite

                                      Is there randomized controlled trial evidence to support the use of information provision in people with stroke and their caregivers? Terry J. Quinn (MD, MRCP, MBChB, BSc) (on behalf of Cochrane Clinical Answers Editors). Cochrane Clinical Answers 2012. DOI: 10.1002/cca.407.

                                      Further Information

                                      • CCA Associate editor: Terry J. Quinn (MD, MRCP, MBChB, BSc), Lecturer, University of Glasgow, Glasgow, UK.
                                      • CCA Editor: Karen Pettersen. Correspondence to kpettersen@wiley.com.